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How to choose a clinical research organization

on July 21, 2011 Source:

Picking a clinical research organization (CRO) has always been about much more than the technical capabilities a potential partner can bring to the table. Adding to the potential confusion is a wave of consolidation as the industry increasingly moves toward a “strategic partnership model,” in which CROs take on a greater role in the development and commercialization of new drugs.

So technical concerns like therapeutic expertise are important when analyzing the top clinical research organizations. And, of course, cost is a factor in any business decision.

But a CRO’s ability to act as a good representative of its client drug or medical device company when interacting with clinicians and other staff at a research site can go a long way in determining a successful clinical trial.

“If the CRO is a big bully, for lack of a better word, it’s really going to affect the relationship the sponsoring company has with the hospital,” said Sandy Maddock, CEO of IMARC Research in Fairview Park, Ohio, a 22-employee CRO started in 1999.

With that in mind, IMARC staff offered the following guidelines drug and device firms should keep in mind when assessing a CRO’s “soft” skills.

Gauge its relationship with hospitals. Maintaining a strong relationship with personnel from the hospital where a clinical trial is being run is important for numerous reasons. For example, it will make the hospital much more likely to quickly and efficiently enroll new patients in the trial. It will also make it far more likely that the hospital becomes a customer once the drug or device involved in the trials is approved for sale.

“You better have a CRO that represents you well or the business ramifications can be pretty severe,” said John Lehmann, IMARC’s director of business development.

Ask about the CRO’s hiring process. Does the company emphasize people skills in interviews with prospective employees? Research protocols can change frequently throughout the course of a trial, so CRO employees need to be strong communicators who can adapt to change — and explain those changes to clinical personnel at the research site.

Evaluate the CRO’s training programs. A good training program presents CRO employees with a wide range of possible scenarios and gives them ideas on how to act and what to say in potentially dicey situations. “If you don’t have the discussion, you can’t assume the employee will know what the expectation is,” Maddock said.

Meet the team. Get a feel for the personalities of several employees, not just executives. Run through hypotheticals to get a sense of how they’d react to challenging circumstances. Ask for examples on how they’ve handled those circumstances in the past.

Set expectations. Discuss past horror stories and give examples of how CRO employees should’ve acted differently. Be clear on exactly how CRO workers should interact with personnel at the research site. “If the CRO ruins that relationship the sponsor company has put lots of time and money into cultivating, they’ve not only put the trial at risk of not enrolling, they’ve potentially disenfranchised their client’s future customer,” Maddock said.

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